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S Emery

Publications and source records attributed to S Emery.

At least 37 records · Page 2Linked to original sources
PubMed2000

A randomised, open-label comparison of three highly active antiretroviral therapy regimens including two nucleoside analogues and indinavir for previously untreated HIV-1 infection: the OzCombo1 study.

BACKGROUND: Highly active antiretroviral therapy (HAART) including two nucleoside analogues and a potent protease inhibitor is standard of care initial therapy for HIV-infected adults. The best-tolerated and most potent initial HAART regimen is unknown and was investigated in this study. METHODS: One hundred and nine HIV-infected adults with no prior antiretroviral therapy, and CD4 lymphocyte counts < 500 x 10(6) cells/l or plasma HIV RNA > 30,000 copies/ml were randomized to zidovudine-lamivudine-indinavir (ZDV-3TC-IDV), stavudine-lamivudine-indinavir (d4T-3TC-IDV) or stavudine-didanosine-indinavir (d4T-ddI-IDV) for 52 weeks. The primary endpoints were plasma HIV RNA and drug-related adverse events. Other assessments were overall safety, adherence and adverse events, CD4 lymphocyte counts, cutaneous delayed type hypersensitivity (DTH) responses and quality of life (Euroqol). RESULTS: Only 58% patients had HIV RNA < 50 copies/ml plasma at 12 months, with no significant difference between the three regimes (P = 0.34). Drug-related adverse events sufficiently severe to warrant drug discontinuation were less common (P = 0.06) in patients receiving d4T-3TC-IDV (18%) than in those receiving ZDV-3TC-IDV (34%) or d4T-ddI-IDV (41%). The percentages of patients who remained on their assigned therapy with plasma HIV RNA < 50 copies/ml at 52 weeks were 60% with d4T-3TC-IDV, 53% with ZDV-3TC-IDV and 35% with d4T-ddI-IDV. Virological failure at 52 weeks was more likely in those whose adherence was estimated to be < 100% in the first 4 weeks of therapy (P = 0.02), but not in those who developed grade 3 or 4 drug-related adverse events. At 52 weeks, the mean CD4 lymphocyte count increase was 200 x 10(6) cells/l with only 7% of patients having counts lower than at baseline; DTH responses improved but remained clinically impaired in most patients. Quality of life improved significantly in all groups. CONCLUSIONS: Initial HAART regimens including IDV failed to suppress plasma HIV RNA to < 50 copies/ml in > 40% patients after only 12 months of therapy although there was significant overall improvement immunologically and in quality of life. The type of dual nucleoside combination used was less important in predicting virological failure than was imperfect adherence early in therapy. Consideration should be given to modifying a HAART regimen relatively early in non-adherent patients.

Adult↗
PubMed2000

A randomized, controlled, phase II trial comparing escalating doses of subcutaneous interleukin-2 plus antiretrovirals versus antiretrovirals alone in human immunodeficiency virus-infected patients with CD4+ cell counts >/=350/mm3.

A total of 73 patients with baseline CD4+ cell counts >/=350 cells/mm3 who were receiving combination antiretroviral therapy (ART) were randomized to receive subcutaneous interleukin-2 (IL-2; n=36) in addition to ART or to continue ART alone (n=37). Subcutaneous IL-2 was delivered at 1 of 3 doses (1.5 million international units ¿MIU, 4.5 MIU, and 7.5 MIU per dose) by twice-daily injection for 5 consecutive days every 8 weeks. After 24 weeks, the time-weighted mean change from baseline CD4+ cell count was 210 cells/mm3 for recipients of subcutaneous IL-2, compared with 29 cells/mm3 for recipients of ART alone (P<.001). There were no significant differences between treatment groups for measures of plasma human immunodeficiency virus RNA (P=.851). Subcutaneous IL-2 delivered at doses of 4.5 MIU and 7.5 MIU resulted in significant increases in CD4+ cell count (P=.006 and P<.001, respectively), compared with that seen in control patients. These changes were not significant in the 1.5 MIU dose group compared with that in the control patients (P=.105). Side effects that occurred from subcutaneous IL-2 administration were generally low grade, of short duration, and readily managed in an outpatient environment.

Adult↗
PubMed2000

Use of calibrated viral load standards for group M subtypes of human immunodeficiency virus type 1 to assess the performance of viral RNA quantitation tests.

Optimal management of human immunodeficiency virus type 1 (HIV-1) disease requires accurate quantitation of viral RNA concentrations in plasma. Evidence for increasing geographic intermixing of HIV-1 subtypes makes equivalent quantitation of all subtypes essential. The performances of six quantitative viral RNA tests are described, for the first time, with calibrated viral isolates of diverse subtypes.

Acquired Immunodeficiency Syndrome↗
PubMed2000

Evaluation of performance of the Gen-Probe human immunodeficiency virus type 1 viral load assay using primary subtype A, C, and D isolates from Kenya.

Accurate and sensitive quantification of human immunodeficiency virus type 1 (HIV-1) RNA has been invaluable as a marker for disease prognosis and for clinical monitoring of HIV-1 disease. The first generation of commercially available HIV-1 RNA tests were optimized to detect the predominant HIV-1 subtype found in North America and Europe, subtype B. However, these tests are frequently suboptimal in detecting HIV-1 genetic forms or subtypes found in other parts of the world. The goal of the present study was to evaluate the performance of a new viral load assay with non-subtype B viruses. A transcription-mediated amplification method for detection and quantitation of diverse HIV-1 subtypes, called the Gen-Probe HIV-1 viral load assay, is under development. In this study we examined the performance of the Gen-Probe HIV-1 viral load assay relative to that of the commonly used commercial HIV-1 RNA assays using a panel of primary isolates from Kenya. For comparison, we included several subtype B cloned viruses, and we quantified each virus using an in-house quantitative-competitive reverse transcriptase PCR (QC-RT-PCR) method and gag(p24) antigen capture. The Gen-Probe HIV-1 viral load assay and a version of the Roche AMPLICOR HIV-1 MONITOR test (version 1.5) that was designed to detect a broader range of subtypes were both sensitive for the quantification of Kenyan primary isolates, which represented subtype A, C, and D viruses. The Gen-Probe HIV-1 viral load assay was more sensitive for the majority of viruses than the Roche AMPLICOR HIV-1 MONITOR test version 1.0, the Bayer Quantiplex HIV RNA 3.0 assay, or a QC-RT-PCR method in use in our laboratory, suggesting that it provides a useful method for quantifying HIV-1 RNAs from diverse parts of the world, including Africa.

Adult↗
PubMed2000

Characterizing and identifying "hard-core" smokers: implications for further reducing smoking prevalence.

OBJECTIVES: Some smokers may never quit. Depending on how many of these "hard-core" smokers exist, tobacco control efforts could reach the limits of a minimum achievable smoking prevalence. We defined the hard core as heavy smokers with weak quitting histories who expect never to quit smoking. We compared them with other smokers and analyzed whether they represent a meaningful barrier to further reducing smoking prevalence. METHODS: We used data from the 1996 California Tobacco Surveys (18616 adults; response rate = 72.9%). RESULTS: In 1996, 5.2% of California smokers 26 years and older (1.3% of the California population) were hard-core smokers. Compared with other smokers, hard-core smokers were more likely to be retired non-Hispanic White males, with 12 years or less of education and incomes below $30,000 a year, who live alone. They began smoking at younger ages and attributed fewer negative health consequences to smoking than other smokers. CONCLUSIONS: Current tobacco control efforts have a long way to go before they "hit the wall." Nonetheless, the group of hard-core smokers represents a challenge because they appear to be largely unaffected by the messages of tobacco control.

Adult↗
PubMed1999

The social costs of tobacco advertising and promotions.

Recent longitudinal evidence suggests that approximately 34% of all new tobacco experimentation occurs because of tobacco advertising and promotions. Based on this figure, in this paper we estimate the long-term impact on mortality and morbidity, as well as the economic and medical costs associated with smoking that is attributable to cigarette advertising and promotions in the United States. This study used several data sources, including the Teenage Attitudes and Practices Survey (TAPS), the 1993 and 1996 Adolescent California Tobacco Surveys (CTS), and the Food and Drug Administration's estimates of annual illness-related benefits of alternative effectiveness rates of banning tobacco advertising. Our resulting estimates are that in each year between 1988 and 1998, tobacco advertising and promotional activities generated approximately 193000 additional adult smokers who began smoking as adolescents because of advertisements and promotions. That decade of tobacco advertising and promotions will also result in approximately 46400 smoking-attributable deaths per year and 698400 years of potential life lost, which translates into costs of approximately $21.7 billion to $33.3 billion in total medical, productivity, and mortality-related costs. Even accounting for quitting behavior, each year of advertising-attributable smoking increases the number of smokers in the population. We conclude that annual costs can be expected to continue to increase if tobacco advertising and promotional activities are not effectively eliminated. If all tobacco industry advertising and promotional activities were banned for the next 25 years, nearly 60000 smoking-attributable deaths per year could be avoided, saving nearly 900000 life-years, $2.6 billion in excess medical expenses, and between $28 billion and $43 billion in mortality costs.

Adolescent↗
PubMed1998

Effects of IL-2 therapy in asymptomatic HIV-infected individuals on proliferative responses to mitogens, recall antigens and HIV-related antigens.

The effects of IL-2 therapy on lymphoproliferative responses to mitogens, recall antigens and HIV epitopes were studied in asymptomatic HIV-infected patients enrolled in a phase II study of intermittent continuous intravenous (Ci.v.) IL-2 and subcutaneous infusions of polyethylene glycol-modified (PEG) IL-2. Sixteen consecutive patients randomized to receive Ci.v. IL-2 (n = 5), PEG IL-2 (n = 7) or anti-viral therapy alone (n = 4) were studied. All patients were vaccinated with tetanus toxoid (TT) before receiving therapy. Proliferative responses to phytohaemagglutinin (PHA), soluble anti-CD3, TT, streptokinase/streptodornase (SK/SD) and 11 previously described HIV-specific T-helper epitopes from gag and env were studied at weeks 0, 16, 30 and 48. Median CD4+ lymphocyte increases of 272 and 255CD4+ cells/microl were observed in the Ci.v. IL-2 and PEG IL-2 groups at week 48, while decreasing by 104 cells/microl in the anti-retroviral therapy alone group. At each time point proliferative responses to PHA, anti-CD3, TT and SK/SD were not different between treatment arms. Similarly, no differences in responses to HIV epitopes were found between the groups and no new responses to HIV epitopes were detected. IL-2 therapy results in a significant increase in peripheral blood CD4+ lymphocyte count, but this increase is not associated with quantifiable improvements in lymphoproliferative responses to mitogens, recall or HIV antigens.

Adult↗
PubMed1998

Outpatient continuous intravenous interleukin-2 or subcutaneous, polyethylene glycol-modified interleukin-2 in human immunodeficiency virus-infected patients: a randomized, controlled, multicenter study. Australian IL-2 Study Group.

The safety and activity of outpatient-based continuous intravenous interleukin-2 (CIV IL-2) or a slow-release, polyethylene glycol (PEG)-modified IL-2 were studied in human immunodeficiency virus (HIV)-infected persons with CD4 cell counts between 200 and 500/mm3. One hundred fifteen patients were randomized to antiretroviral therapy plus cyclical CIV IL-2 (n = 27), subcutaneous PEG IL-2 (n = 58), or no IL-2 (n = 30). Toxicity withdrawal rates were low (4% for CIV IL-2 and 7% for PEG IL-2). There were median CD4 cell count increases of 359 and 44 cells/mm3 and a decline of 46 cells/mm3 in the 3 groups, respectively, over 1 year (P < .0001 for each intergroup comparison). CD4 cell count increases were greatest in those with lower HIV RNA load. Delayed-type hypersensitivity scores increased and HLA-DR expression on CD8 cells decreased significantly with IL-2 therapy. HIV RNA levels were unaffected. IL-2 therapy may expand the existing immune repertoire but not immediately reconstitute lost immune function.

Adult↗
PubMed1998

The end of the Injury Severity Score (ISS) and the Trauma and Injury Severity Score (TRISS): ICISS, an International Classification of Diseases, ninth revision-based prediction tool, outperforms both ISS and TRISS as predictors of trauma patient survival, hospital charges, and hospital length of stay.

INTRODUCTION: Since their inception, the Injury Severity Score (ISS) and the Trauma and Injury Severity Score (TRISS) have been suggested as measures of the quality of trauma care. In concept, they are designed to accurately assess injury severity and predict expected outcomes. ICISS, an injury severity methodology based on International Classification of Diseases, Ninth Revision, codes, has been demonstrated to be superior to ISS and TRISS. The purpose of the present study was to compare the ability of TRISS to ICISS as predictors of survival and other outcomes of injury (hospital length of stay and hospital charges). It was our hypothesis that ICISS would outperform ISS and TRISS in each of these outcome predictions. METHODS: "Training" data for creation of ICISS predictions were obtained from a state hospital discharge data base. "Test" data were obtained from a state trauma registry. ISS, TRISS, and ICISS were compared as predictors of patient survival. They were also compared as indicators of resource utilization by assessing their ability to predict patient hospital length of stay and hospital charges. Finally, a neural network was trained on the ICISS values and applied to the test data set in an effort to further improve predictive power. The techniques were compared by comparing each patient's outcome as predicted by the model to the actual outcome. RESULTS: Seven thousand seven hundred five patients had complete data available for analysis. The ICISS was far more likely than ISS or TRISS to accurately predict every measure of outcome of injured patients tested, and the neural network further improved predictive power. CONCLUSION: In addition to predicting mortality, quality tools that can accurately predict resource utilization are necessary for effective trauma center quality-improvement programs. ICISS-derived predictions of survival, hospital charges, and hospital length of stay consistently outperformed those of ISS and TRISS. The neural network-augmented ICISS was even better. This and previous studies demonstrate that TRISS is a limited technique in predicting survival resource utilization. Because of the limitations of TRISS, it should be superseded by ICISS.

Adult↗
PubMed1998

The conundrum of the Glasgow Coma Scale in intubated patients: a linear regression prediction of the Glasgow verbal score from the Glasgow eye and motor scores.

BACKGROUND: The Glasgow Coma Scale (GCS), which is the foundation of the Trauma Score, Trauma and Injury Severity Score, and the Acute Physiology and Chronic Health Evaluation scoring systems, requires a verbal response. In some series, up to 50% of injured patients must be excluded from analysis because of lack of a verbal component for the GCS. The present study extends previous work evaluating derivation of the verbal score from the eye and motor components of the GCS. METHODS: Data were obtained from a state trauma registry for 24,565 unintubated patients. The eye and motor scores were used in a previously published regression model to predict the verbal score: Derived Verbal Score = -0.3756 + Motor Score * (0.5713) + Eye Score * (0.4233). The correlation of the actual and derived verbal and GCS scales were assessed. In addition the ability of the actual and derived GCS to predict patient survival in a logistic regression model were analyzed using the PC SAS system for statistical analysis. The predictive power of the actual and the predicted GCS were compared using the area under the receiver operator characteristic curve and Hosmer-Lemeshow goodness-of-fit testing. RESULTS: A total of 24,085 patients were available for analysis. The mean actual verbal score was 4.4 +/- 1.3 versus a predicted verbal score of 4.3 +/- 1.2 (r = 0.90, p = 0.0001). The actual GCS was 13.6 + 3.5 versus a predicted GCS of 13.7 +/- 3.4 (r = 0.97, p = 0.0001). The results of the comparison of the prediction of survival in patients based on the actual GCS and the derived GCS show that the mean actual GCS was 13.5 + 3.5 versus 13.7 + 3.4 in the regression predicted model. The area under the receiver operator characteristic curve for predicting survival of the two values was similar at 0.868 for the actual GCS compared with 0.850 for the predicted GCS. CONCLUSIONS: The previously derived method of calculating the verbal score from the eye and motor scores is an excellent predictor of the actual verbal score. Furthermore, the derived GCS performed better than the actual GCS by several measures. The present study confirms previous work that a very accurate GCS can be derived in the absence of the verbal component.

Glasgow Coma Scale↗
PubMed1997

Safety and immunogenicity of UBI HIV-1MN octameric V3 peptide vaccine administered by subcutaneous injection.

Twenty-four HIV-seronegative men, at high risk of HIV infection, were recruited into a phase I/II safety and immunogenicity trial of a prototype HIV vaccine. The immunogen was a synthetic, monovalent, octameric HIV-1MN V3 peptide in an aluminum hydroxide (alum) adjuvant. The vaccine had been evaluated previously using a standard 0-, 1-, 6-month intramuscular schedule and was found to stimulate neutralizing antibody in 60-90% of volunteers. Participants were randomized to receive either 500 micrograms (n = 10; high dose) or 100 micrograms (n = 10; low dose) of immunogen or placebo (alum alone; n = 4) at 0, 1, and 6 months by subcutaneous injection. Responses to the immunogen were evaluated by enzyme-linked immunosorbent assay (ELISA)-detectable antibody and by proliferative responses. Safety was monitored by both clinical assessment and regular review with a clinical psychologist. No serious adverse experiences were observed following administration of the assigned medication. One individual (placebo) seroconverted while on study, following exposure to HIV. After the vaccination course only four individuals (three high dose and one low dose) had ELISA-detectable antibody against the immunogen. In the evaluable samples, from 19 volunteers, only 7 vaccine recipients (3 high dose and 4 low dose) had demonstrable lymphoproliferative responses to preparations of the immunogen. Subcutaneous administration of its candidate vaccine was safe but did not result in uniform or robust immunological responses.

AIDS Vaccines↗
PubMed1997

Immune reconstitution in HIV infection.

Progressive immune deficiency arising during HIV disease reflects the continual degradation and the ultimate deletion of immune specificites defined by the CD4(+) T lymphocyte repertoire. Recent evidence suggests that improvements in the immune function of patients with HIV who receive therapy primarily reflects the expansion of CD4(+) T lymphocyte populations present before therapy commenced. These observations have implications for clinical management, therapeutic strategies, and future research.

Acquired Immunodeficiency Syndrome↗